BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA INFORMATION SYSTEM

    MDR report key: 2626923 · Received June 24, 2012

    Report

    Report Number
    1722028-2012-00381
    Event Type
    Malfunction
    Date Received
    June 24, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    NYO
    PMA / PMN Number
    BK070066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: THE PROCEDURE WAS ABORTED RIGHT AFTER PRIME DUE TO AN INFILTRATION AND NO BLOOD WAS DRAWN FROM THE DONOR. THE DONOR DID NOT HAVE A REACTION DURING THE PROCEDURE, NOR DID THEY PRESENT ANY ISSUES AFTERWARD AND NO MEDICAL INTERVENTION WAS PERFORMED. THIS IS A SOFTWARE PRODUCT WHICH DOES NOT HAVE AN ASSOCIATED TECHNICAL FILE, SIMPLY A BATCH WORK ORDER WHICH WOULD DOCUMENT ANY PRODUCTION DEFECTS. A REVIEW OF THE PRODUCT DISPOSITION FILE SYSTEM FOR THIS CATALOG NUMBER WAS PERFORMED AND NO RECORDS WERE FOUND. ROOT CAUSE: OPERATOR ERROR. THE CUSTOMER'S SALES PERSON, WAS NOTIFIED SO THAT HE COULD FOLLOW UP WITH THE CUSTOMER AND POSSIBLY CONSIDER SOME RE-TRAINING FOR THE OPERATORS.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE THE PATIENT INFORMATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A DONOR WAS ASSIGNED TO A MACHINE, BUT THEN A DIFFERENT DONOR WAS RUN ON THAT MACHINE USING THE ORIGINAL DONOR'S INFO. THE DONOR WHO WAS ACTUALLY DRAWN ON THE MACHINE HAD A SMALLER TBV THAN THE ORIGINAL DONOR, BUT THE RUN WAS ABORTED IMMEDIATELY AFTER PRIME. THERE WAS NO DONOR REACTION AND NO BLOOD WAS DRAWN SUCCESSFULLY FROM THE DONOR. PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO AN OPERATOR ERROR THAT WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR INJURY IF THIS SAME FAILURE WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA INFORMATION SYSTEM VISTA INFORMATION SYSTEM NYO TERUMO BCT 923000320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other